MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO CURVED SINUS BURS; BUR, EAR, NOSE AND THROAT

Model Number 1883212HS

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

It was reported that a blade broke during a case.It broke while the doctor was working on the patient, but did not occur until the case was almost completed.They were able to complete the case using a new bur.The break was at the hub and there were no reported fragments.There was no patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: no analysis results available; evaluation expected but not yet begun.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

Date received: (b)(6), 2014.(b)(6).Product evaluation: when received for analysis, there was evidence of biologicals from visual inspection and reactivity with hydrogen peroxide.The hub and a portion of the inner shaft were separate from the rest of the device, and the tip of the bur was recessed into the outer tube.The inner shaft was broken 0.62" from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there were striations at the break point indicating metal on metal contact and an uneven break.The information indicates excess pressure was applied during use which caused deformation of the locking area, which then caused the inner shaft and outer tube to rub together until the inner shaft broke.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CURVED SINUS BURS
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4329479
• MDR Text Key: 5213001
• Report Number: 3004209178-2014-23924
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2021
• Device Model Number: 1883212HS
• Device Catalogue Number: 1883212HS
• Device Lot Number: H9170350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 12/15/2014
• Supplement Dates Manufacturer Received: Not provided; 12/16/2014
• Supplement Dates FDA Received: 01/08/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00019 YR
• Patient Weight: 84